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    Home > Can TCM clinics make traditional Chinese medicine preparations?

    Can TCM clinics make traditional Chinese medicine preparations?

    Echemi 2019-05-15

    Can-TCM-clinics-make-traditional-Chinese-medicine -preparations

    Article 32 of the Law on Traditional Chinese Medicine, which came into effect on July 1, 2017, stipulates that "only varieties of traditional Chinese medicine preparations prepared by traditional technology can be prepared after filing with the drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government where the medical institutions are located, without obtaining the approval number of the preparations." After the promulgation of Chinese Medicine Law, the former State Administration of Food and Drug Administration promulgated in February 2018 a bulletin on the application of traditional technology to the preparation of traditional Chinese medicine preparations in medical institutions (hereinafter referred to as the "bulletin"), clarifying the scope of traditional Chinese medicine preparations, the materials required for the filing and the filing procedures, etc. The provincial drug regulatory departments at the provincial level issued the bulletin. Yemen has issued detailed rules for the implementation of filing. So far, the traditional Chinese medicine preparation filing system has been fully implemented.

    In September 2017, the former National Health and Family Planning Commission issued the "Interim Measures for the Management of Chinese Medicine Clinic Records" Article 2. It stipulates: "The Chinese medicine clinics referred to in this method, under the guidance of traditional Chinese medicine theory, use of traditional Chinese medicine and non-drug therapies such as acupuncture, cupping, massage, to carry out diagnosis and treatment services, and adjustment of Chinese medicine. Clinic of Traditional Chinese Medicine Pharmaceutical Services such as Decoction of Pharmaceutical Agents and Decoctions. These Measures shall not apply to those who fail to meet the scope of service as prescribed above or who have uncontrollable hidden dangers and risks of medical safety." Article 14 of the Law of Traditional Chinese Medicine stipulates that if a Chinese medicine clinic is held, the name, address, scope of diagnosis and treatment and staffing of the clinic shall be reported to the competent department of traditional Chinese medicine of the local people's government at the county level for the record, and then the practicing activities can be carried out. Chinese medicine clinics shall publicize the scope of their diagnosis and treatment, the name of the Chinese medicine physician and the scope of their practice in the obvious location of the clinic, and shall not carry out medical activities beyond the scope of filing.

    According to the Notice on the Issuance of Basic Standards of Traditional Chinese Medicine Clinics and Basic Standards of Traditional Chinese Medicine Clinics issued by the former National Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine on December 1, 2017, it is stipulated that the Basic Standards of Traditional Chinese Medicine Clinics are applicable to the Chinese Medicine Clinics under the archival management, which is one of the necessary conditions for the establishment of the Chinese Medicine Clinics for the archival management.( The Basic Standards of Comprehensive Clinic are applicable to Chinese and Western medical service and to Chinese and Western medical clinics which do not meet the scope of service stipulated in the Interim Measures for the Recording Management of Chinese Medical Clinics or which have uncontrollable medical safety risks. It is the lowest standard that the practice of Chinese medicine (comprehensive) clinics must meet. It is also the license of Medical Institutions issued by the administrative department of health and family planning and the competent department of Chinese medicine. Business License and the basis for verification. From this, it can be seen that the definition of TCM clinics is limited and should not go beyond the scope of filing, which is different from the traditional Chinese medicine (comprehensive) clinics which are under the examination and approval system. Before the promulgation of the Law on Traditional Chinese Medicine, the main regulatory documents related to the preparation of medical institutions included the Law on Drug Administration, the Regulations on the Implementation of the Law on Drug Administration, the Measures for the Registration and Administration of Pharmaceutical Agents in Medical Institutions (Trial Implementation), and the Standards for the Quality Control of Preparations in Medical Institutions (Trial Implementation). The above-mentioned documents construct a legal system for the supervision of pharmaceutical preparations in medical institutions, and carry out an examination and approval system for pharmaceutical preparations in medical institutions. Preparations prepared by medical institutions shall be those that are not available on the market for their clinical needs and may be prepared only after approval by the drug regulatory authorities of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located. Preparations prepared must be tested for quality in accordance with the regulations and used in the medical institutions on the basis of prescriptions of doctors.

    The traditional Chinese medicine preparations prescribed in announcement include: solid (pills, powder, dan, ingot, etc.), semi-solid (ointment, plaster, etc.) and liquid (decoction) traditional dosage forms made from crushed or extracted pieces of Chinese medicine, granules made from water and glue made from crushed pieces of Chinese medicine. Capsules; alcoholics and tinctures extracted from Chinese herbal slices by traditional methods. Decoction is a kind of traditional Chinese medicine preparation. In June 2005, the former State Food and Drug Administration promulgated Article 5 of the Measures for the Registration and Administration of Preparations in Medical Institutions (for trial implementation), which stipulates that: "The applicant for pharmaceutical preparations in medical institutions shall be a medical institution holding a Medical Institution License and obtaining a Medical Institution Preparations License." Medical institutions that have not obtained the Pharmaceutical License of Medical Institutions or the Pharmaceutical License of Medical Institutions and have no corresponding dosage form of `hospital'category may apply for the preparation of traditional Chinese medicine in medical institutions, but they must also submit the application for entrusting the preparation at the same time.

    TCM clinics belong to medical institutions, which are clearly stipulated in the Regulations on the Administration of Medical Institutions and the Rules for the Implementation of Regulations on the Administration of Medical Institutions, but TCM clinics do not belong to the category of "hospitals". The former State Food and Drug Administration (SFDA) made it clear in its Reply to the Request for the Scope of Medical Institutions Defining the Category of "Hospital" (Food and Drug Administration Security Letter (No. 111, 2006), "Hospital" refers to general hospitals, traditional Chinese medicine hospitals, traditional Chinese and Western medicine.

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